Yes. Lodging, travel and meals for speakers of an accredited or certified CME event meeting all three requirements in 42 CFR 403.904(g)(1) will be deemed to be included in the total speaker compensation and, therefore, exempt from reporting under Open Payments. However, travel, lodging and meals and all other natures of payments provided in conjunction with the accredited or certified CME event (with the exception of educational materials included in the tuition fees for an accredited or certified CME program that meets all three exemption conditions, such as handouts, web downloads or printed slides) will need to be reported for physician attendees (who are not speakers). These payments would need to be reported under the appropriate nature of payment categories, such as food and beverage, travel and lodging, or entertainment, as appropriate. The excluding characteristic for meals is when allocating the cost of the meal among covered recipients in a group setting where the cost of each individual covered recipient's meal is not separately identifiable.

Analysis

CMS has clarified that applicable manufactures and GPO's are not required to report faculty payments and expenses associated with the accredited CME events (those that meet the required three conditions: (1) accreditation; (2) no direct payment to speaker/faculty fromt he manufacturer; and (3) no input whatsoever from the manufacturer such as providing lists).

CMS further clarified that travel, lodging and meals associated with accredited CME events will need to be reported for physician-attendees, unless it is in a group setting where the cost of each individual covered recipient's meal is not separately identifiable. An example of this includes buffets and box lunches for accredited CME events in group settings i.e. grand rounds and symposium where it is difficult to figure out the value of the meal and who partook in the meal.

The question of whether an applicable manufacturer must report a buffet meal provided to physician attendees at an unaccredited educational program taking place at a large annual conference requires a fact-specific inquiry as to whether it is difficult for the manufacturer "to definitively establish the identities of the physicians, who partake in the food or beverage." (78 Fed. Reg. 9479) The preamble explains that the exception in 42 CFR 403.904(h)(2) only applies to situations where an applicable manufacturer provides a large buffet meal, snacks or coffee that are made available to all conference attendees and where it would be difficult to establish the identity of the physicians, who partook in the meal or snack. This exception does not apply to meals provided to select attendees at a conference where the sponsoring applicable manufacturer can establish the identity of the attendees.

Analysis

For product theaters at national conferences, companies may have to report the value of the meal to participants in those non-accredited events.

No. The final rule exempted payments to medical residents from the reporting requirements solely due to operational and data accuracy concerns regarding aggregation of payments or other transfers of value to residents, many of whom have neither a National Provider Identifier (NPI) nor a State professional license. Because these same concerns do not generally apply to physicians in Fellowship training, payments to Fellows are not exempt from the reporting requirements.

Analysis

Applicable Manufactures and Group Purchasing Organizations will have to report the value of interactions related to Fellows. Full compliance may be difficult as some states do not require licensure of fellows. For fellows education the rules around accredited and non-accredited programs apply to fellows.

Yes. Educational materials that are included in the tuition fees for an accredited or certified CME program that meets all three exemption conditions, such as handouts, web downloads or printed slides, are excluded from reporting under Open Payments provided that the content does not contain any CME sponsor information, the content is related to the CME program, the value is de minimis, and the funds used for the materials came from the same CME program grant.

Analysis

CMS recognized the value of educational support materials distributed at educational events. As long as the funds for the educational materials came from the CME grant and is of minimum value, then there is no requirement to track and report the value of the educational materials.

The value of a journal reprint should reflect the cost that an applicable manufacturer or applicable group purchasing organization paid to acquire the reprint from the publisher or other distributor. Applicable manufacturers and applicable group purchasing organizations may submit an assumptions document clarifying any assumptions made to determine the value of journal reprints.

Analysis

CMS has developed a uniform reporting system for journal reprints which is the cost of the acquisition of the reprints from the publisher by the manufacturer or GPO divided amongst the individual recipients. Companies have the opportunity to submit their method of calculation of the value of reprints to CMS for review. This may help CMS further understand the reprint process.

Commentary

These answers will assist manufacturers and GPO's in accurately reporting payments associated with the physician payment sunshine act. Washington Legal Foundation has raised constitutional questions about including education items such as books and reprints in reporting.

Questions still remain with accredited CME including further clarification on the other accreditation bodies that meet the accreditation standards of one of the five listed accrediting bodies including the ACPE (Pharmacists), COPE (Optometrists) and the AANC (Nurses). With less than 30 day to recording payments, companies have limited time to prepare for some of the changes coming from the Q&A.Other questions answered by CMS include:

Yes. There is no reporting exclusion for payments made by applicable manufacturers or applicable group purchasing organizations to covered recipients for the purpose of purchasing products or materials